Epilepsy Clinical Trial
— NIBMSZSOfficial title:
Neuroimaging Biomarker for Seizures
Verified date | April 2022 |
Source | Providence VA Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This multi-site study will examine patients with epilepsy (ES) following head injury [i.e., posttraumatic epilepsy (PTE)] and posttraumatic psychogenic Non-epileptic seizures (PNES) and will compare them to patients with traumatic brain injury (TBI) who do not have seizures using functional neuroimaging.
Status | Active, not recruiting |
Enrollment | 224 |
Est. completion date | September 14, 2022 |
Est. primary completion date | May 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Inclusion criteria for PNES, ES and TBI (w/o PNES or ES) participants - Individuals with history of documented TBI (any severity). - Males and Females ages 18-60 years . - Women of child bearing potential, if currently using appropriate contraception. Inclusion criteria of PNES and ES participants. - Diagnosed by video/EEG with lone PNES or by EEG with lone ES. - Patients must have at least 1 PNES or 1 ES during the year prior to enrollment. Exclusion Criteria: - Exclusion Criteria of PNES, ES and TBI (w/o PNES or ES) participants - Current or past year self-injurious behavior. - Current suicidal intent (BDI suicide question 9 score of >1). - Current or past year psychosis. - Pending litigation or current application for long term disability. - Active substance or alcohol use disorder (dependence), per discretion of the investigators. - Serious illness requiring systemic treatment or hospitalization; the participant either completes therapy or is clinically stable on therapy, for at least 30 days prior to study entry. - Inability to fill out the self-report surveys. - Women who are or/are attempting to become pregnant during the study. - Ineligible or unwilling to complete MRI imaging. - Inability to document TBI. Exclusion Criteria for PNES and ES participants - Inability or unwillingness to participate in CBT and assigned homework. - Currently enrolled in cognitive therapy aimed at PNES (Current CBT or other psychotherapy may be administered). - Concurrent mixed ES/PNES or equivocal video/EEG findings in discerning between ES and PNES will not be enrolled. |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Providence VA Medical Center | Providence | Rhode Island |
United States | Rhode Island Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Providence VA Medical Center | Birmingham, Alabama VA Medical Center, Brown University, Ocean State Research Institute, Inc., Rhode Island Hospital, United States Department of Defense, University of Alabama at Birmingham |
United States,
Allendorfer JB, Szaflarski JP. Physiologic and cortical response to acute psychosocial stress in left temporal lobe epilepsy: response to a biochemical evaluation. Epilepsy Behav. 2014 Dec;41:312-3. doi: 10.1016/j.yebeh.2014.08.018. Epub 2014 Oct 11. — View Citation
Elsas SM, Gregory WL, White G, Navarro G, Salinsky MC, Andrews DJ. Aura interruption: the Andrews/Reiter behavioral intervention may reduce seizures and improve quality of life - a pilot trial. Epilepsy Behav. 2011 Dec;22(4):765-72. doi: 10.1016/j.yebeh.2011.09.030. Epub 2011 Nov 6. — View Citation
LaFrance WC Jr, Baird GL, Barry JJ, Blum AS, Frank Webb A, Keitner GI, Machan JT, Miller I, Szaflarski JP; NES Treatment Trial (NEST-T) Consortium. Multicenter pilot treatment trial for psychogenic nonepileptic seizures: a randomized clinical trial. JAMA Psychiatry. 2014 Sep;71(9):997-1005. doi: 10.1001/jamapsychiatry.2014.817. — View Citation
LaFrance WC Jr, Friedman JH. Cognitive behavioral therapy for psychogenic movement disorder. Mov Disord. 2009 Sep 15;24(12):1856-7. doi: 10.1002/mds.22683. Erratum in: Mov Disord. 2010 Oct 15;25(13):2268. — View Citation
LaFrance WC Jr, Keitner GI, Papandonatos GD, Blum AS, Machan JT, Ryan CE, Miller IW. Pilot pharmacologic randomized controlled trial for psychogenic nonepileptic seizures. Neurology. 2010 Sep 28;75(13):1166-73. doi: 10.1212/WNL.0b013e3181f4d5a9. Epub 2010 Aug 25. — View Citation
LaFrance WC Jr, Syc S. Depression and symptoms affect quality of life in psychogenic nonepileptic seizures. Neurology. 2009 Aug 4;73(5):366-71. doi: 10.1212/WNL.0b013e3181b04c83. — View Citation
Michaelis R, Schonfeld W, Elsas SM. Trigger self-control and seizure arrest in the Andrews/Reiter behavioral approach to epilepsy: a retrospective analysis of seizure frequency. Epilepsy Behav. 2012 Mar;23(3):266-71. doi: 10.1016/j.yebeh.2011.11.023. Epub 2012 Feb 15. — View Citation
Reiter JM, Andrews DJ. A neurobehavioral approach for treatment of complex partial epilepsy: efficacy. Seizure. 2000 Apr;9(3):198-203. — View Citation
Salinsky M, Spencer D, Boudreau E, Ferguson F. Psychogenic nonepileptic seizures in US veterans. Neurology. 2011 Sep 6;77(10):945-50. doi: 10.1212/WNL.0b013e31822cfc46. — View Citation
Szaflarski JP, Ficker DM, Cahill WT, Privitera MD. Four-year incidence of psychogenic nonepileptic seizures in adults in hamilton county, OH. Neurology. 2000 Nov 28;55(10):1561-3. — View Citation
Szaflarski JP, Hughes C, Szaflarski M, Ficker DM, Cahill WT, Li M, Privitera MD. Quality of life in psychogenic nonepileptic seizures. Epilepsia. 2003 Feb;44(2):236-42. — View Citation
Voon V, Brezing C, Gallea C, Ameli R, Roelofs K, LaFrance WC Jr, Hallett M. Emotional stimuli and motor conversion disorder. Brain. 2010 May;133(Pt 5):1526-36. doi: 10.1093/brain/awq054. Epub 2010 Apr 5. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Epileptic Seizures | epileptic seizure frequency (ES), collected prospectively, using a daily seizure calendar | Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline | |
Primary | Number of Nonepileptic Seizures (NES) | psychogenic nonepileptic seizure (NES) frequency, collected prospectively, using a daily seizure calendar | Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline | |
Primary | Structural and Functional Neuroimaging | Brain MRI scans | Baseline and week 13 | |
Secondary | Beck Depression Inventory-II (BDI-II) | The BDI-II assesses depression severity from "0" (no Depression-related symptom) to "3" (severe) on each question. The highest possible score is "51", relating to the worst outcome. | Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline | |
Secondary | Beck Anxiety Inventory (BAI) | The BDI-II assesses anxiety severity from "0" (no Anxiety-related symptom) to "3" (severe) on each question. | Baseline, Weeks 6 and 10, 8 months post baseline, 12 months post baseline | |
Secondary | Quality of Life in Epilepsy-31 (QOLIE-31) | his is a 31-item self-report scale used in the seizure population to evaluate Quality of Life. The lowest possible score is 0 and the highest possible score is 100, reflecting a better quality of life. | Baseline, Weeks 6 and 10 |
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